Advances In Treatment Of Epilepsy And Related Seizure Disorders Help Improve Quality Of Life

Epilepsy and seizures affect 2.5 million Americans, 181,000 new cases of epilepsy are diagnosed every year, and the disorder incurs an estimated $12.5 billion in annual direct and indirect costs. About 450,000 children ages 15 and younger develop epilepsy each year, and of these, 315,000 are school-aged children. Children and adolescents are more likely to have epilepsy of unknown or genetic origin. The rate of new cases in children is highest before age 2, gradually declines until about age 10, and then stabilizes.

“Brain injury or infection can cause epilepsy at any age; however, the cause of epilepsy is unknown for about half of all individuals with the disorder,” said Howard Weiner, MD, a pediatric epilepsy neurosurgeon at NYU Comprehensive Epilepsy Center, and an American Association of Neurological Surgeons (AANS) spokesperson. Children may be born with a defect in the structure of their brain, or they may suffer a head injury or infection that causes their epilepsy. Severe head injury is the most common known cause in young adults. In middle age, strokes, tumors, and injuries are more frequent cause. In people age 65 and older, stroke is the most common known cause, followed by degenerative conditions such as Alzheimer’s disease. Seizures may not begin immediately after a person incurs a brain injury ??” seizures may occur many months later.

The emotional and physical toll can have a very negative impact on patients with refractory epilepsy. Uncontrolled seizures may cause significant physical injury or accidents, as well as cause cognitive disturbances, poor school or work performance, inability to work, and progressive memory deterioration. People with epilepsy may feel socially isolated and limited, thus diminishing their quality of life. The families of patients may also be significantly impacted emotionally by the disorder.

According to the AANS, tremendous advances have been made in epilepsy treatment over the past decade. Epilepsy may be treated with drug therapy, surgery, biofeedback, vagus nerve stimulation (VNS) or a ketogenic diet. The wide range of antiepileptic drugs (AEDs) remains the cornerstone of treatment.

AEDs treat the symptoms of epilepsy (the seizures), rather than curing the underlying condition. The drugs act on the brain to prevent the seizures from starting by reducing the tendency of the brain cells to send excessive and confused electrical signals. Before any drug is prescribed, it is important to discuss potential benefits, side effects and risks with your doctor.

Brain surgery may be a viable alternative for some people whose seizures cannot be controlled by medication. A person who has been given adequate dosages of several seizure medications, for an appropriate period of time without good results, is unlikely to achieve complete seizure control with any other medication.

Epilepsy surgery can benefit patients who have seizures associated with structural brain abnormalities, such as benign brain tumors and cortical dysplasia, malformations of blood vessels (such as arteriovenous malformations and cavernous angiomas), the genetic disorder tuberous sclerosis, and strokes. The goal of epilepsy surgery is to identify an abnormal area of brain cortex from which the seizures originate and remove it without causing any major functional impairment.

Surgery is most commonly performed to treat partial epilepsy, since only one area of the brain is involved. After surgery, many patients will be seizure-free, while others will have better controlled seizures. A few patients may not improve and will need to explore further treatment options.

In some cases, a palliative approach is used to stop the spread of seizures, when the actual seizure focus cannot be determined accurately. One such approach involves cutting the nerve fibers connecting the two sides of the brain through a corpus callosotomy. The corpus callosum is a band of nerve fibers located deep in the brain that connects the two sides (hemispheres) of the brain. It helps the hemispheres share information, but it also contributes to the spread of seizure impulses from one side of the brain to the other.

Some conditions are associated with seizures arising from one entire half of the brain one hemisphere which is not functioning normally. A functional hemispherectomy is a surgical procedure performed in these cases, in which the epileptic, non-functioning hemisphere is disconnected from the remaining, normal hemisphere in order to stop the seizures.

“Depending on how well the seizure focus can be defined, between 50 and 90 percent of children who have epilepsy surgery stop having seizures entirely or experience a major reduction in the number of seizures. Many people in the field believe that the earlier in a child’s development that surgery is performed, the better the outcome,” stated Dr. Weiner.

Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 6,800 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain, and peripheral nerves.

American Association of Neurological Surgeons (AANS)
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Advanced Melanoma: Vaccine Shows Therapeutic Promise

A vaccine for one of the most lethal cancers, advanced melanoma, has shown improved response rates and progression-free survival for patients when combined with the immunotherapy drug, Interleukin-2, according to researchers from The University of Texas M. D. Anderson Cancer Center.

The findings, presented at the American Society of Clinical Oncology (ASCO), mark the first vaccine study in the disease – and one of the first in cancer overall – to show clinical benefit in a randomized Phase III clinical trial. Patrick Hwu, M.D., professor and chair of M. D. Anderson’s Department of Melanoma Medical Oncology, presented the findings on ASCO’s press program.

According to the American Cancer Society, melanoma has one of the fastest growing incidence rates of all cancers. In 2009, more than 68,720 people in the U.S. are projected to be diagnosed with melanoma and 8,650 will likely die from the disease. The five-year survival rates for those with regional and metastatic disease are 65 percent and 16 percent, respectively.

“Obviously, this is a disease, in its advanced setting, in need of better therapies for our patients,” said Hwu, a co-investigator on the study. “While more follow up is needed, this study serves as a proof-of-principle for vaccines’ role in melanoma and in cancer therapy overall. If we can use the body’s own defense system to attack tumor cells, we provide a mechanism for ridding the body of cancer without destroying healthy tissue.”

During their tenure at the National Cancer Institute (NCI), Hwu and Douglas Schwartzentruber, M.D., who is currently medical director of the Goshen Center for Cancer Care, were involved in the vaccine’s development and early basic and clinical studies. The peptide vaccine, known as gp100:209-217 (200M), works by stimulating patients’ T cells, known for controlling immune responses.

“This vaccine activates the body’s cytotoxic T cells to recognize antigens on the surface of the tumor. The T cells then secrete enzymes that poke holes in the tumor cell’s membrane, causing it to disintegrate,” explained Hwu.

After an NCI-led Phase II study combining the vaccine with Interleukin-2 (IL-2) showed response rates of 42 percent in metastatic melanoma patients, a Phase III randomized trial with the two agents opened more than a decade ago.

Conducting a large, multi-institutional trial with IL-2, however, had its own set of unique challenges, explained Hwu, as not all cancer centers and community hospitals are capable of administering the immunotherapy. A highly specialized therapy associated with such significant side effects as low blood pressure and capillary leak syndrome, which poses risks to the heart and lung, IL-2 is often delivered in intensive care units. Just last month, M. D. Anderson opened a special in-patient unit exclusively designed for the drug’s delivery; before, the institution was offering the therapy in its ICU.

In the Phase III trial, 185 patients at 21 centers across the country were enrolled in the study. All had advanced metastatic melanoma and were stratified for cutaneous metastasis, a known indicator of response to IL-2. Patients were randomized to receive either high dose IL-2, or IL-2 and vaccine. In the IL-2 arm, 94 patients were enrolled and 93 were treated and evaluated for response; 91 were enrolled and 86 treated and evaluated in the IL-2 and vaccine arm.

The study found that those who received the vaccine had a significant response rate, 22.1 percent, and progression-free survival, 2.9 months, compared to 9.7 percent and 1.6 months respectively in those that did not. While not statistically significant, the median overall survival for those receiving vaccine trended positive, 17.6 months vs. 12.8 months.

“This is one of the first positive, randomized vaccine trials in cancer and the findings represent a significant step forward for treatment of advanced melanoma,” said Schwartzentruber, the study’s lead author. “However, we’ve learned a lot over the last decade, and we need to incorporate these new discoveries as we proceed with our validation of this vaccine.”

Schwartzentruber, who with Hwu was involved in the earlier trials and the vaccine’s development, presented the findings on ASCO’s plenary session on May 30.

Hwu agreed that more research with the vaccine is needed, including long-term follow up of the Phase III patients, as well as researching ways to make the study inclusive of more metastatic melanoma patients.

“Right now, the vaccine only can be given to half of those with melanoma because it has to match a patient’s tissue type, or HLA. A major priority for us is to figure out ways to broaden our approach and use mixtures of peptides so that more patients are eligible,” Hwu said. “We also would like to improve upon it by including other immune-stimulatory agents, such as anti-CTLA4, an antibody that can take the breaks off the immune cells.”

The study was funded, in part, by the National Cancer Institute and Novartis, the makers of IL-2.

In addition to Hwu and Schwartzentruber, other collaborators on the study include: David Lawson, M.D., Winship Cancer Institute; Jon Richards, M.D., Ph. D., Lutheran General Hospital Cancer Care Center; and Robert M. Conry, M.D., UAHSF Comprehensive Cancer Center.

Source:
Laura Sussman

University of Texas M. D. Anderson Cancer Center Continue reading

Children Enrolled In Medicaid Have More Untreated Tooth Decay, Witnesses Say

Children covered under Medicaid receive considerably less dental care and have more untreated tooth decay than those who are privately insured, witnesses testified during a recent hearing held by the House Oversight and Government Reform Domestic Policy Subcommittee, CQ HealthBeat reports. According to CQ HealthBeat, a Government Accountability Office report released last month found that an estimated 6.5 million children covered by Medicaid had untreated tooth decay in 2005.

Alicia Cackley, acting director of health care at GAO, in written testimony said that children covered by Medicaid between 1999 and 2004 were almost twice as likely to have untreated tooth decay. She added that 15% of children in Medicaid had difficulty receiving dental care because the provider did not accept their insurance plan, compared with 2% of privately insured children.

James Crall, director of the National Oral Health Policy Center at University of California-Los Angeles, said “chronically low” reimbursement rates discourage many dentists from participating in the program. He added that increases in provider reimbursement have increased the rate of children covered by Medicaid using dental services in several states. He also suggested streamlining provider enrollment and separating dental benefits from the rest of the Medicaid program to “allow states to retain greater control in setting reimbursement rates, and allow for reasonable profits on the part of the dental benefits managers while eliminating the incentive to reduce payments to dentists who provide dental services to Medicaid beneficiaries.”

Witnesses from several states testified that raising reimbursement rates, streamlined enrollment procedures and improved outreach programs have increased access to dental care for children covered by Medicaid. Herb Kuhn of CMS said the agency has completed reviews of 17 states with low dental utilization rates and will release the findings in a national report. He added that the agency wants to improve access to dental care, reimbursement rates for providers and evaluations of which services are provided (Straus, CQ HealthBeat, 10/3).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

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Blue Cross Blue Shield Of Michigan Broadens Medicare Options With New Medicare Advantage PPO Product

Blue Cross Blue Shield of Michigan announced a new Medicare Advantage PPO product that for many Michigan seniors provides benefits at lower premiums than Original Medicare coupled with Part D drug plans and supplementary coverage.

“Our new Medicare Advantage PPO provides the comprehensive coverage seniors want, including prescription drugs and benefits Original Medicare doesn’t provide,” said Mark Owen, BCBSM vice president for federal programs and individual business.

Blue Cross launched the PPO to replace two current Private-Fee-For Service (PFFS) Medicare Advantage products – Options C and D – whose premiums would have been most negatively affected by reductions in government funding for Medicare Advantage, coupled with medical cost increases for Michigan beneficiaries that in some cases are twice as high as the national average.

“We know that many seniors stay in the products they are enrolled in, without shopping around,” Owen said. “We decided that it would be better to replace these two products with an affordable PPO option, rather than impose large premium increases onto the people enrolled in them. All of the beneficiaries in our C and D plans are being notified by letter, we have briefed senior assistance agencies on our changes, and Blue Cross stands ready to assist beneficiaries with making the right product choice for their health care needs.”

BCBSM Medicare Advantage premiums and products for 2010 are changing due to federal government reimbursement cuts and increased medical costs.

Two other current BCBSM Private Fee for Service products, Medicare Plus Blue Options A and B, will remain in place for 2010. Their premiums also will be affected by reductions in government funding and increases in medical costs.

Called Medicare Plus Blue PPO, the new Medicare Advantage PPO product will have a network of more than 18,000 Michigan physicians and 136 Michigan hospitals and will be available in 75 out of 83 Michigan counties.

Medicare Plus Blue PPO also provides services that are not available in Original Medicare or Medicare Supplemental plans. The following are examples of some of these:

– preventive dental services

– routine physicals

– expanded home infusion therapy

– world wide coverage for emergency care

– prescription drug coverage

– total body skin exams

Care management tools and resources through BlueHealthConnection that help members navigate the complexities of our health care system and support them in regaining and maintaining their health and independence.

October 1 is the first day BCBSM and Medicare Advantage carriers across the nation can market their Medicare Advantage products for 2010. Beneficiaries in BCBSM Medicare Advantage products will receive letters in the next 10 days about the new product line-up.

“Blue Cross remains fully committed to providing products to Medicare beneficiaries and will continue to have the broadest array of Medicare Advantage products in the state,” said Mark Owen, BCBSM vice president for federal and individual business. “It’s important for Medicare beneficiaries to know that there is no immediate change to their coverage. They have until the end of the year to make their selection for 2010.”

In addition to the three BCBSM products for 2010, seniors also can select from three Medicare Advantage products offered by Blue Care Network, the BCBSM-affiliated HMO.

“We will be working with insurance agents and other groups across the state to reach out to Medicare beneficiaries to help them navigate these product and premium changes,” said Owen.

Seniors who meet low income guidelines can receive subsidies from the state and/or federal government to pay for all or part of their premiums.

Medicare Advantage premiums vary by product and region. The new PPO product is expected to provide beneficiaries with value for their premium. For example, the BCBSM Medicare Plus Blue PPO, which includes Part D prescription drug coverage, will cost between $61 and $141 a month (premiums vary by geographic region), while traditional BCBSM Medicare Supplemental (Medigap) Plan C plans cost $183 when combined with a stand-alone Part D BCBSM prescription drug program.

Medicare Advantage plans offer Medicare benefits through private health insurance plans and most include Part D prescription drug coverage. When you purchase a Medicare Advantage plan, you do not need to also purchase a Medigap policy. Medicare Advantage plans are regulated solely by the federal government, while Medigap plans are regulated by the state. The announced product changes are only for Medicare beneficiaries who directly purchase their Medicare Advantage products, not for beneficiaries enrolled in a group plan.

Blue Cross Blue Shield of Michigan and Blue Care Network are nonprofit corporations and independent licensees of the Blue Cross and Blue Shield Association.

Source: Blue Cross Blue Shield of Michigan Continue reading

Blogs Comment On Tweeting About Abortion, ‘Purity’ Movement, Other Topics

The following summarizes select women’s health-related blog entries.

~ “Steph Herold: Tweeting To End Abortion Stigma,” Serena Freewomyn, Feminists for Choice: As part of a weekly series, “Feminist Conversation,” Freewomyn features a Q&A with Steph Herold, a reproductive justice advocate who founded the website IAmDrTiller to commemorate the work of murdered Kansas abortion provider George Tiller and others. Herold “caused quite a stir” by creating the #ihadanabortion hashtag on Twitter, Freewomyn writes. Herold discusses her motivation for starting the blog, her involvement with the New York Abortion Access Fund, and her views on feminism. She also describes the impetus behind the Twitter hashtag, noting that although the “anti-choice movement has tried to make abortion the sin of a few bad women,” in reality, “abortion is a regular part of women’s lives” (Freewomyn, Feminists for Choice, 11/10).

~ “Daddy I Do: ‘Purity’ World is Tough for Women,” Sarah Seltzer, RH Reality Check: A new documentary — “Daddy, I Do” — “explores the ‘purity’ movement and the consequences of abstinence-only policies in America,” Seltzer writes. The documentary suggests that the father-daughter aspects of the purity movement give it “a major ‘creep factor,’ which is one of the reasons that many in America’s mainstream turn away from the idea of abstinence,” Selzter adds. Despite this, “as ‘Daddy I Do’ reminds us, one in six girls actually do pledge purity in America and 90% break that vow.” The documentary also prompts questions about “whether these vow-breakers are armed with the knowledge they need when statistics bear out and they do start ‘sinning’” and “whether the moral and ideological standards of one group has the right to determine, even intrude, on the educational standards of the entire population,” Seltzer continues. She writes that the documentary carries “an overarching theme that whether women are getting used for their bodies or told that their bodies are sacred, these women are defined by men and don’t have control over their own sexuality — which leads to a lack of control over their own identities” (Seltzer, RH Reality Check, 11/10).

~ “Mendacity Exposed: Researcher Debunks the Big Lie on Abortion and Mental Health,” Jodi Jacobson, RH Reality Check: Jacobsen cites a recent column on the Daily Beast that makes the case “about the complicity of both the Obama Administration and the mainstream media in perpetuating lies about [President] Obama’s policies told by the far right during midterm election campaigns.” According to Jacobson, those lies not only “shaped public opinion” but also “the outcome of the election.” She argues that the column’s “analysis can easily be extrapolated to the failure of mainstream media — and of government officials — to do their job in the debate around abortion.” This point “was forcefully and eloquently argued” in a recent Washington Post opinion piece about false claims that abortion causes mental health problems — a claim that has sparked legislation in several states. Jacobson writes that “lies used to advance political and ideological agendas are a central component of the anti-choice uber-strategy, but these same efforts to distract, deflect, and misinform are becoming an increasingly prevalent and uncontested characteristic of our social discourse more broadly.” In “the abortion debate as in the political debate writ large, campaigns gear up to ‘inform’ through misinformation, leading to ‘misinformed choices’ that comport with the agendas of those in power or who wish to be in power,” Jacobson adds (Jacobson, RH Reality Check, 11/10).

~ “Washington State Wants To Let Pharmacies Deny Women Plan B,” Alex DiBranco, Change’s “Women’s Rights”: DiBranco discusses the Washington state Board of Pharmacy’s recent 3-2 vote allowing the board to revise a rule that requires pharmacies to dispense legal medications, including emergency contraception. According to DiBranco, the board likely was forced to revise the rule because it was “faced with the prospect of a lawsuit from a small group of pharmacists opposed to” EC. She notes that board member Dan Connolly was recently quoted in the media as saying that “the state can’t afford to be involved in a lengthy lawsuit.” DiBranco writes, “You know what women seeking emergency contraception can’t afford? To be denied access at their local pharmacy, to run out of time to take the medication because they can’t get to an actual comprehensive provider fast enough, to be faced with an unwanted pregnancy and the decision of whether or not to have an abortion because their attempt to be responsible and take Plan B when their standard birth control method failed was stymied.” She adds that more Washington residents “have already registered their intense disapproval of overturning the established rule, the vast majority of commenters of the opinion that pharmacies shouldn’t be able to refuse legal time-sensitive medication on a whim” (DiBranco, “Women’s Rights,” Change, 11/10).

~ “Anti-Choice Abortion Legislation and Pro-Choice Women Voters,” Amie Newman, RH Reality Check: In an article in The Nation, columnist Katha Pollitt “talks about the relentless pursuit, on the part of anti-choice lawmakers, given the outcome of the midterm elections, to chip away at abortion access in this country,” Newman writes. Newman adds, “During the campaign season, the health care reform law (PL 111-148) provided a perfect foil for anti-choice candidates who needed to find something about abortion to grab onto, as the larger public discussion focused on the state of the economy.” These candidates and the groups that supported them “dug deep into the intricacies of the health care law and pulled out connections between state-created health exchanges (with federal funding), private insurance coverage, and women who may use a combination of both to build some mighty shaky bridges between abortion care and taxpayer money,” Newman writes. Pollitt “gives a great run-down of where she thinks anti-choice lawmakers and supporting groups will focus this session” and “provide[s] some relief” when she notes that abortion-rights supporters likely “made the difference” in some races, she continues. “It’s good to know that pro-choice women hold the key, as long as we use it,” Newman concludes (Newman, RH Reality Check, 11/11).

Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families.

© 2010 National Partnership for Women & Families. All rights reserved.

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Class-Action Suit Medicaid Over Proof-of-Citizenship Law To Be Filed

A class-action lawsuit over a new Medicaid law that would require beneficiaries and applicants to provide proof of citizenship to receive benefits beginning July 1 is expected to be filed Wednesday, the Atlanta Journal-Constitution reports (Kemper, Atlanta Journal-Constitution, 6/28). The measure is included in the Deficit Reduction Act of 2005, which was signed into law by President Bush in February. Under the law, individuals seeking care through Medicaid as of July 1 will be required to show proof of U.S. citizenship, such as a birth certificate, passport or another form of identification. The law’s intent is to prevent undocumented immigrants from claiming to be citizens in order to receive benefits only provided to legal residents (Kaiser Daily Health Policy Report, 4/11). The Congressional Budget Office estimates that the requirement will save the federal government $220 million over five years and $735 million over 10 years. CBO says that by 2015, about 35,000 people — mostly undocumented immigrants — will lose coverage because of the new requirement. However, the Center on Budget and Policy Priorities estimates that three million to five million low-income citizens could lose Medicaid coverage because they do not have birth certificates or passports (Kaiser Daily Health Policy Report, 4/18). The lawsuit — to be filed on behalf of at least four Medicaid beneficiaries who are unable to provide documentation of their citizenship — alleges that current enrollees who already have been declared eligible for Medicaid would be put “through a complex, costly and difficult administrative process to prove the same thing all over again.” Many U.S. residents — including blacks in the South who were denied access to hospital maternity wards during periods of segregation — cannot provide such documentation, according to the lawsuit. Ron Pollack, executive director of Families USA, which is aiding those involved in the lawsuit, said the stricter Medicaid requirement is “part of the backlash and — if I may say — the pandering of members of Congress” as they debate how to deal with the estimated 12 million undocumented immigrants living in the U.S (Atlanta Journal-Constitution, 6/28).

NPR’s “Talk of the Nation” on Tuesday included a discussion of the Medicaid law. The segment includes comments from Leslie Norwalk, deputy administrator of CMS, and Pollack (Conan, “Talk of the Nation,” NPR, 6/27). The complete segment is available online in RealPlayer.

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Allon’s Phase 1 Trial Broadens Davunetide’s Intranasal Safety And Dose Range

Allon Therapeutics Inc. (TSX:NPC) announced today that a Phase 1 clinical trial of its lead neuroprotective drug, davunetide , which began patient enrolment January 28, 2010, has been completed. The results demonstrated that the intranasal dose range can be broadened and provided additional information on the pharmacokinetic profile of davunetide.

Gordon McCauley, President and CEO of Allon, said the results confirm davunetide’s safety and expands the doses that can be used in future clinical trials. The Company’s previous Phase 2a clinical trials successfully demonstrated human efficacy in patients with schizophrenia and in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease.

“These Phase 1 results fully support our dosing plans for a Phase 2 clinical trial that will evaluate davunetide as a treatment for Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease,” McCauley said.

The randomized, double-blind, placebo-controlled Phase 1 study evaluated the multi-dose safety, tolerability and pharmacokinetic profile of davunetide in 10 healthy adult subjects aged 45 to 65 years. Davunetide was administered at a dose up to 60 mg per day, and was found to be generally well tolerated with no serious adverse events reported. The number of treatment emergent AEs were small with a similar number reported in the placebo and the high dose groups. These clinical results support the advancement of davunetide at higher dosage levels in the treatment of neurodegenerative diseases such as Alzheimer’s disease, schizophrenia and PSP.

Allon announced January 12, 2010 that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation to davunetide for the treatment of PSP. PSP is a one of several dementias classified as a frontotemporal dementia (FTD).

Approximately half of dementias diagnosed as FTD, including PSP, have a common pathology in which brain cells are damaged by impairment of the brain protein tau. Allon’s preclinical studies and Phase 2a clinical trials have shown that davunetide is active in treating diseases known to have impaired tau function, leading to restoration of brain cell health. Allon expects that efficacy in PSP would define the opportunity to use davunetide in other FTD subtypes that are tauopathies.

About davunetide

Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s laboratory and animal studies have shown that davunetide improves cognition in a number of disease models through a mechanism believed to involve effects on structures in the brain – known as microtubules which are critical to communication between brain cells and the structure of individual cells.

In 2008, Allon reported Phase 2a clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer’s Disease and Related Disorders (ICAD 2008).

On December 7, 2009, Allon reported Phase 2a clinical trial results showing that davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. The data was presented at the annual meeting of the American College of Neuropsychopharmacology.

About Allon’s neuroprotective platforms

Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).

Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer’s disease, cognitive impairment in schizophrenia, and frontotemporal dementia.

ADNF drug candidate AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.

Source
Allon Therapeutics Inc. Continue reading

Are Our Kids Oversnacked?

Kids aren’t the only ones who smile when the words “snack time” are heard. We are obsessed with snacking. Aisle after aisle in the grocery store is filled with sweet, salty, savory and, yes, even healthy snacks. Do we live in an oversnacked society? Is this fixation adding to the dangerous level of childhood obesity and playing a role in the growing number of poorly nourished kids in our country?

“Despite the increase in weight of our children, there are still critical nutrient gaps,” said Gina Bucciferro, registered dietician and pediatric nutrition expert at Loyola University Medical Center. “Snacks can either make or break the nutritional quality of a kid’s daily intake.”

Research has shown that 88 percent of U.S. children do not meet the recommended daily intake for fruit and 92 percent do not meet the same for vegetables. Though obesity is a major concern for kids with poor nutrition, there are other health risks as well. These include heart disease, depression, high blood pressure, tooth decay, anemia, osteoporosis and diabetes.

According to Bucciferro, snacks are a great way to bridge the nutritional gap. Parents need to be aware of what is being served and when it takes place to help keep snack time a good time.

When to snack:

1. After physical activity. In addition to needing high-quality energy for growth and development, children involved in sports and other physical activities need to replace the extra energy they are burning. Whole grains, fruits, vegetables and low-fat dairy can provide the carbohydrates needed to replenish little athletes without added sugar and fat. Fluids also are important in making sure active kids stay hydrated. According to the American Dietetic Association, school-age children need to drink six 8 ounce cups of water per day and another 8 ounces for every half-hour of strenuous activity. A sports drink is only necessary for activities lasting longer than 60 minutes.

2. Scheduled between meal times. Children do have increased nutrition needs, so providing snacks between meals can help them stay focused and healthy. The goal should be to offer as much nutrition as possible without providing excessive sugar, fat and calories. Fruits, vegetables and low-fat dairy are an easy way to meet this goal. These types of foods, eaten two to three hours before a meal will not spoil an appetite, whereas high-fat foods might.

When not to snack:

1. As a reward. Our relationship with food is formed at a very young age. When food is provided as a reward an unhealthy relationship with food can be formed. Rewarding children with playtime or fun, educational activities can form much better habits than indulging in high-fat, high-sugar fare. Also, providing these types of foods after an accomplishment can lead the child to place a higher value on low-nutrition food items. Also, don’t treat these foods as forbidden. Encourage everything in moderation.

2. To cure boredom. Starting a habit of eating when bored can become a slippery slope. If you notice your child requesting snacks at off-times, make sure to assess the situation. If your child’s normal meal times have been thrown off due to a hectic schedule or if they’ve had increased activity, provide them with a small, low-calorie snack such as fruit and low-fat yogurt or veggies and light ranch dip. However, if it’s been a typical day and you notice your child is just antsy, provide a fun activity instead. Depending on your child’s age coloring and other activity books can be a good option for minimal supervision while not encouraging increased television time.

“Snack time can be beneficial for kids. Just make sure kids are snacking at the right time and that snack items are closing the nutrient gaps, not worsening a child’s nutrient deficit which be detrimental to a child’s health,” said Bucciferro.

Source:
Loyola University Health System Continue reading

Cognitive Impairment Associated With Reduced Survival Among Both African-American And White Older Adults

Alzheimer’s disease and its precursor, mild cognitive impairment, appear to be associated with an increased risk of death among both white and African American older adults, according to a report in the June issue of Archives of Neurology, one of the JAMA/Archives journals.

Alzheimer’s disease reduces life expectancy and has emerged as a leading cause of death in the United States, according to background information in the article. “Data from two national surveys suggest that life expectancy among patients with Alzheimer’s disease may be greater for African Americans than for whites,” the authors write. “However, not all surveys have reported this difference. Furthermore, in these surveys, the diagnosis of Alzheimer’s disease is not based on a uniform clinical evaluation but derived from medical records, increasing the likelihood of substantial variation in the quality of diagnostic classifications.”

Robert S. Wilson, Ph.D., and colleagues at Rush University Medical Center, Chicago, studied 1,715 older adults (average age 80.1, 52.5 percent African American) from four adjacent neighborhoods in Chicago. Each participant had a clinical evaluation that included medical history, a neurological examination and cognitive (thinking, learning and memory) function testing. Based on these evaluations, an experienced physician diagnosed 296 (17.3 percent) of the participants with Alzheimer’s disease, 597 (34.8 percent) with mild cognitive impairment and 20 (1.2 percent) with other forms of dementia, while 802 (46.8 percent) had no cognitive impairment.

During up to 10 years of follow-up (average observation period, 4.7 years) 634 individuals died (37 percent), including 25.8 percent of those without cognitive impairment, 40.4 percent of those with mild cognitive impairment, 59.1 percent of those with Alzheimer’s disease and 60 percent of those with other forms of dementia. “Compared with people without cognitive impairment, risk of death was increased by about 50 percent among those with mild cognitive impairment and was nearly three-fold greater among those with Alzheimer’s disease,” the authors write. “These effects were seen among African Americans and whites and did not differ by race.”

Among individuals with mild cognitive impairment, risk of death increased as cognitive impairment became more severe, another association that did not differ by race. A similar association between disease severity and survival was seen among patients with Alzheimer’s disease, although that effect was slightly stronger for African Americans than for whites.

“Overall, these results do not suggest strong racial differences in survival for persons with mild cognitive impairment and Alzheimer’s disease,” the authors conclude.

Arch Neurol. 2009;66[6]:767-772.

Source
Archives of Neurology Continue reading

COMPORTA: New Technologies In The Service Of The Disabled

In many cases persons with limited mobility in their upper limbs; those with muscular dystrophy, those suffering from certain nervous and muscular disorders such as cerebral palsy, lose the ability of moving their wrists and arms and, thereby, may have difficulties handling certain devices, such as a computer mouse or keyboard or a TV remote control pad. In the COMPORTA project, work is being carried out with these people severely disabled in the upper limbs. The aim of the project is to adapt a portable communicator that will have various applications for these persons.

Xmadina Tecnolog?­a Adaptativa, S.L.; Eleka Ingeniaritza linguistikoa, S.L.; Robotiker; Minos 97 and the Bidaideak association have all participated in this project.

COMPORTA is based on the use of PDAs (Personal Digital Assistant), also known as electronic agendas. Given their small size and weight, they are totally portable and are easy to use anywhere. This is why PDAs are so useful for persons with neurophysical disabilities, and can help with greater personal autonomy; in effect, they enhance one??s quality of life. This is because they can be used to communicate anywhere, listen to music of one??s choice, search the Web or control the television set.

Nevertheless, those with disabilities in the arms and hands may have problems in handling the buttons and tactile screens of the usual PDAs. In order to provide a solution to this, an adaptation has been made of Etsedi, a PC application created for the Xmadina company.

Editing text

Etsedi created a virtual keyboard on the PC screen, reducing the complete virtual keyboard of the commercially available variety to just eight keys. Taking into account that many people with limited mobility are capable of handling the control pad for a wheelchair with great precision and skill, the distribution of the 8 keys has been designed so that they can be selected by means of movements similar to those of these control pads. That is to say, the virtual keys are selected with movements carried out in one plane, in different directions.

The Etsedi application edits texts in Windows. Having a choice of various menus, the user may write numbers, text or special characters. Each virtual key has a set of characters that have been grouped together on the basis of an analysis of combination frequencies, while taking into account that these combinations never occur and, thus, introducing the text is facilitated and optimised. Besides, the application predicts the words that the user wishes to write. As the user keys in a word, the programme automatically comes up with up to 16 possible words around the 8 virtual keys, in such a way that a simple movement can directly select the desired word. The dictionary used by the application for this prediction can be updated and adapted by the user to his or her needs.

The COMPORTA project has adapted this application to PDAs and has developed the same system of prediction for the Basque language. Further, they wish to extend the functions so the device can be used for electronic mail, surfing the Net, and so on.

Giving a voice to the text

People disabled in the upper limbs often have problems in speaking. This is why COMPORTA, by means of a virtual keyboard, adds a voice to the written text. Using voice synthesisers and text-to-speech technology, the text keyed in by the end-user is heard through the speakers

This part of the project has been the task of Eleka Ingeniaritza Linguistikoa and, although applications of this technology exist in other languages, this is the first time in Euskara.

Thus, it will be a bilingual PDA, voice synthesising in both Basque and Spanish, enabling the end-user to use either language. Moreover, different tones of voice are available, the user being able to employ the tone of their choice and which best befits their personality, sex, age, etc.

Remote Control

The PDA can also be useful for controlling various everyday devices. This is why, at COMPORTA, they want the PDA also to be a remote control one for various utilities controlled through the PC. This means the PC would have the software necessary to control the TV, the music centre, the DVD, etc., and the PDA would send the corresponding commands to the PC to control this software.

Wheelchair tuning

So that the PDA is genuinely portable, a support will be designed which will be an articulated arm adaptable to different models of wheelchair and which can also be used to support other items.

The device will have small speakers incorporated which will have sufficient power and quality to be used in noisy environments, such as the street. Current PDAs have inbuilt speakers but they are not very powerful; the new, reinforced system will guarantee quality in communication.

And all this, for how much?

There currently exist a number of devices for the disabled on the market. However, unfortunately many disabled persons are denied access to these because, according to the INE (Instituto Nacional de Estad?­stica) their price is prohibitive. This is why COMPORTA have focused on the final product being accessible for this target group of people.

The solution adopted was the use of commercial hardware with adapted software. In most cases, the hardware is specialised. In this case, however, it is one that is manufactured in great numbers, thus reducing the price considerably. Moreover, in choosing a PDA amongst mobile communicators, the economic factor was also taken into consideration, as these are also cheaper than other communicators.

Internet reference
eleka/

Contact: Ibon Aizpurua

Elhuyar Fundazioa Continue reading